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510(k) Data Aggregation
K Number
K232978Device Name
DX. Bond V Dental Bonding Adhesive
Manufacturer
Sino-Dentex Co., Ltd.
Date Cleared
2023-09-22
(366 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Sino-Dentex Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite
Device Description
DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
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